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A phase I/II study of Lonsurf combined with Oxaliplatin in metastatic colorectal cancer patients refractory to standard chemotherapy.

ABSTRACT: Interventions: Lonsurf/L-OHP therapy Lonsurf: 70mg/m2, d1-5, d15-19 (fixed dose) L-OHP: 50-85mg/m2, d1,d15 (dose escalation) every 4 weeks Primary outcome(s): [Phase I part] To determine recommended dose (RD) and maximum tolerated dose (MTD) [Phase II part]Disease Control Rate (DCR) Study Design: Single arm Non-randomized

DISEASE(S): Metastatic Colorectal Cancer

PROVIDER: 2631090 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Phase 1 Trial of Lonsurf with Irinotecan and Bevacizumab

Project description:Interventions: 1 cycle is 28days. Lonsurf(25mg/m2)is administered orally twice daily in 1-5days and 8-12 days. Irinotecan(100mg/m2) and Bevacizumab(5mg/kg) is administered by injection in day 1 and day15. Primary outcome(s): Recommended dose:RD Study Design: single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose

| 2615622 | ecrin-mdr-crc

Phase I/II study of the combination of Oxaliplatin and S-1 in patients with advanced/recurrent colorectal cancer

Project description:Interventions: S-1 is administered orally at the dose of 40mg/m2 twice a day for 21 days, followed by 7-14 days rest. L-OHP is administered intravenously biweekly(day 1 and 15). On 2nd steps L-OHP is administered with RD intravenously biweekly more than 2 courses. The doses of L-OHP are 70mg/m2 for level 1, 85mg/m2 for level 2, and 55mg/m2 for level 0. Primary outcome(s): Step1:safety;adverse events Step2:Disease control rate Study Design: Single arm Non-randomized

| 2609838 | ecrin-mdr-crc

Phase 1 Trial of Lonsurf with Irinotecan and Bevacizumab in Patients with Unresectable Metastatic Colorectal Cancer(mCRC).

| 2634299 | ecrin-mdr-crc

Use-results survey for Lonsurf combination tablet T15 & Lonsurf combination tablet T20

Project description:Intervention name : Lonsurf combination tablet T15/T20 INN of the intervention : trifluridine + tipiracil hydrochloride Dosage And administration of the intervention : Usually, the standard doses below are defined as the initial dose (single dose) for adults according to body surface area (approximately 35 mg of Trifluridine/m2/dose). Lonsurf is administered twice daily, after breakfast and after the evening meal, for 5 consecutive days, followed by a 2-day rest. After repeating this twice, follows a 14-day rest. This is one cycle of the regimen and it shall be repeated. Study Design: Postmarketing surveillance

| 2611187 | ecrin-mdr-crc

Use-results survey for Lonsurf combination tablet T15 & Lonsurf combination tablet T20

Project description:Interventions: investigational material(s) Generic name etc : Lonsurf combination tablet T15/T20 INN of investigational material : trifluridine + tipiracil hydrochloride Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Usually, the standard doses below are defined as the initial dose (single dose) for adults according to body surface area (approximately 35 mg of Trifluridine/m2/dose). Lonsurf is administered twice daily, after breakfast and after the evening meal, for 5 consecutive days, followed by a 2-day rest. After repeating this twice, follows a 14-day rest. This is one cycle of the regimen and it shall be repeated. Study Design: Postmarketing surveillance

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A Phase II Study of Neoadjuvant Gemcitabine Plus Doxorubicin Followed by Gemcitabine Plus Cisplatin in Breast Cancer

Project description:This phase II study examined the pathological complete response (pCR) rate and safety of two gemcitabine-based combinations administered sequentially in breast cancer. We also examined gene expression profiles from tumor biopsies to identify biomarkers predictive of response. Methods: Indian women with large or locally advanced breast cancer received 4 cycles of gemcitabine 1200 mg/m2 plus doxorubicin 60 mg/m2 (Gem+Dox), then 4 cycles of gemcitabine 1000 mg/m2 plus cisplatin 70 mg/m2 (Gem+Cis), and surgery. To examine dynamic changes in molecular profiles after one dose of therapy, we used three alternate sequences during cycle 1 (Gem d1, 8; Dox d2; Gem d1, 8; Dox d1; or Gem d2, 8; Dox d1). Results: Of 65 women (median age 46) treated, 13 (24.5% of 53 patients with surgery) had a pCR and 22 (33.8%) had a complete clinical response. Patients who received Gem d1, 8 and Dox d2 in cycle 1 (20/65) reported more toxicities, with G3/4 neutropenic infection/febrile neutropenia (7/20) and vomiting (5/20) as the most common cycle 1 events. Four drug-related deaths occurred. 46/65 patients yielded successful pretreatment gene expression profiles. Ten-fold cross-validated supervised analyses identified gene expression patterns that predicted with >73% accuracy (1) clinical complete response after eight cycles, (2) overall clinical complete response, and (3) pCR. Conclusions: This neoadjuvant regimen showed strong activity. A subset of patients receiving Gem d1, 8 and Dox d2 experienced unacceptable toxicity, whereas patients on other sequences had more manageable safety profiles. The predictive gene expression patterns may provide a method for selecting patients most likely to benefit from gemcitabine-containing neoadjuvant therapy. Key words: breast cancer, chemotherapy, gemcitabine, , gene expression, microarrays, neoadjuvant therapy Keywords: Dose response

2008-01-12 | GSE8465 | GEO

First-in-human Study of CA102N Monotherapy and CA102N Combined With Trifluridine/Tipiracil (LONSURF) in Subjects With Advanced Solid Tumors

Project description:Study HS-CA102N-101 is a phase 1, two part (dose escalation, dose expansion), multicenter, non-randomized, open-label, multiple dose, first-in-human study of CA102N monotherapy and of CA102N combined with trifluridine/tipiracil (LONSURF) in subjects with advanced solid tumors. CA102N will be evaluated in subjects with locally advanced or metastatic solid tumours for which no effective therapy is available in Part 1 (dose escalation) and in subjects with relapsed or refractory locally advanced or metastatic colorectal cancer (mCRC) after prior oxaliplatin and irinotecan-based chemotherapy in Part 2 (dose expansion).

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A Phase I /II Study of Bi-weekly XELIRI with Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy.

Project description:Interventions: XELIRI+ bevacizumab Capecitabine:2000mg/m2/day d1-8 Irinotecan:180mg/m2 d1 Bevacizumab:5mg/kg d1 Q2w Primary outcome(s): Phase I part To determine Safety in 1st cycle by Bi-weekly XELIRI+bevacizumab. Phase II part Progression Free Survival Study Design: Single arm Non-randomized

| 2619445 | ecrin-mdr-crc

Study on the effects of metformin and cimetidine on the exposure of trifluridine/tipiracil (lonsurf) in patients with a metastatic colorectal carcinoma

Project description:Primary objectives: 1. To determine the possible drug interaction between Lonsurf and metformin on Lonsurf plasma pharmacokinetics (AUC) in patients with metastatic colorectal cancer.2. To determine the possible interaction between Lonsurf and cimetidine on Lonsurf plasma pharmacokinetics (AUC) in patients with metastatic colorectal cancer. of concomitant administration of Lonsurf with metformin and cimetidine on Lonsurf and metformin exposure. Primary endpoints: To determine the influence of concomitant administration of Lonsurf with metformin and cimetidine on Lonsurf and metformin exposure.

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Cetuximab plus S-1 and irinotecan (IRIS) as first-line treatment in RAS wild type metastatic colorectal cancer, a phase I/II trial (KSCC1401)

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| 2631161 | ecrin-mdr-crc

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